Validation Engineer - Medical Devices

Validation Engineer - Medical devices

Medasil Surgical Ltd

Leeds | Full Time | Permanent | On-site

Working Hours:

Monday: 8:00am–4:30pm

Tuesday–Thursday: 7:30am–4:30pm

Friday: 7:30am–2:00pm

About Medasil Surgical Ltd

Medasil Surgical Ltd is a specialist medical device manufacturer based in Leeds. We manufacture medical devices within a regulated environment, with quality and compliance central to our manufacturing operations. We are seeking a Validation Engineer to join our Technical and Engineering team.

The Role

The Validation Engineer will be responsible for the planning, execution, documentation and maintenance of validation and verification activities across the company’s manufacturing operations.

The role covers the validation and verification of manufacturing equipment, processes, tooling, test methods, software, facilities and associated systems used in the manufacture of medical devices.

The Validation Engineer will work closely with Engineering, Production, Quality Assurance, Regulatory Affairs and other relevant departments to ensure that equipment, processes and systems are appropriately qualified and remain in a validated state throughout their lifecycle.

Key Responsibilities

• Plan, develop and execute validation and verification activities in accordance with approved procedures, validation plans and the company’s Quality Management System.
• Prepare and execute (IQ), (OQ) and (PQ) protocols and reports.
• Develop validation strategies, protocols, test methods, acceptance criteria and sampling plans.
• Validate and qualify manufacturing equipment, tooling and associated processes.
• Work with equipment and processes including injection moulding, extrusion, compression moulding, ovens, washing, assembly, sealing and inspection/test equipment.
• Support the preparation and review of Process FMEAs and other risk assessments.
• Identify Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs) and other characteristics requiring control or verification.
• Provide validation input into engineering and quality change controls and determine requirements for qualification, verification or revalidation.
• Support the introduction and qualification of new equipment, processes, tooling, software and manufacturing technologies.
• Maintain accurate, complete and traceable validation documentation and records.
• Support internal, customer, Notified Body and regulatory audits relating to validation and engineering activities.
• Assist with the preparation and maintenance of the Site Validation Master Plan, validation schedules and validation status documentation.
• Identify opportunities for improvement in validation processes, manufacturing processes and equipment performance.

Experience and Knowledge

Skills and Attributes

The role requires:

• Strong analytical and problem-solving skills.
• Excellent attention to detail.
• The ability to investigate technical problems and identify appropriate root causes.
• Excellent written and verbal communication skills.
• The ability to write clear validation protocols, reports, risk assessments and technical documentation.
• Good understanding of data analysis and the ability to interpret validation and process performance data.
• The ability to work independently and as part of a cross-functional team.
• Good time management and organisational skills.
• The ability to manage multiple validation activities and meet agreed deadlines.
• The ability to adapt to changing priorities and work effectively under time constraints.
• The ability to maintain accurate and traceable validation records.
• The ability to communicate effectively with Engineering, Production, Quality, Regulatory Affairs, suppliers and external contractors.
• The confidence to challenge processes, assumptions and technical conclusions where appropriate and provide evidence-based recommendations.
• Good working knowledge of Microsoft Word and Excel, including using Excel for validation data analysis.
• The ability to work on the manufacturing floor and within controlled/cleanroom environments where required.

Working at Medasil

The Validation Engineer will work as part of the Technical and Engineering team and will have regular interaction with Engineering, Production, Quality Assurance and Regulatory Affairs.

The role involves both office-based technical and documentation work and practical activity within the manufacturing environment. The successful candidate will be expected to work independently on assigned validation projects while maintaining effective communication with relevant teams.

Application

To apply for this position, please submit your CV and a covering letter outlining your relevant experience in validation, engineering and/or regulated manufacturing.